Not a SaMD - How to be submitted for marketing authorization in EU and USA

#1
Hi Group,

Not a SaMD like DICOM Edit, Fast View etc. when marketed with Medical device follows the Regulatory requirements in EU and US. Could anyone share, as to how a non- medical software OR a general software independently (not coupled with medical device) has to be submitted for marketing authorization in EU and USA. Please guide as to what are the requirements for conformity ?
 
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Marcelo

Inactive Registered Visitor
#2
If it's not a medical device, it does not follows medical device regulations. You would ned to verify which kind of regulations the software has to follow, but it's too general a question to be answered properly (and also, you probably won't find an answer in the Medical Device Forums, I will move the question to another forum).
 
#3
Hi Marcelo,

I am writing a guideline for marketing authorization of software products like the below, that will help Service Engineers,

Can you please let me know, if this by any chance falls under the medical device classification. I referred to your information material on Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR
Does the point that the trainings upgrade the skills (smart simulators) and help clinicians in investigation and diagnosis matter ? Could you also share the MDR and FDA requirement/checklist for device classification.
 
Last edited:

Watchcat

Trusted Information Resource
#4
FDA follows a different regulatory framework from the EU. It does not have checklist for device classification, because the classification of most devices is determined by their similarity to other devices already on the US market. The rest, FDA classifies itself, one device at a time.

For medical devices, FDA has a website that has been designed for use by small companies (e.g., lots of information, reasonably easy to find for a government website, and written in reasonably easy to understand language, for a government website. If you are writing a guideline for others to follow, I would recommend you rely as much as possible on authoritative sources, not internet forums, for your information.

I recommend you start with CDRH Learn:

CDRH Learn

Click on the drop-down menu, "Start here/The Basics!" This will display four presentations. I recommend you skip the first two (your topic is too narrow for them to be helpful) and start with the third one, "Is my Product a Medical Device?" The website provides the presentation as a webinar, the slides, and the full transcript of the presentation. It has a good bit of information on software and lots of links to take you to more information on a specific topic.

If you have specific questions about FDA's information, or encounter language that is confusing, then come on back to the Cove for assistance in answering questions and understanding what FDA is telling you.

Enjoy!
 

Ronen E

Problem Solver
Staff member
Moderator
#5
Beautiful response @Watchcat

To complete, the situation in the EU is not as neat. The "new" MDR will soon apply (May 2020), and sadly much of the supporting infrastructure is not yet in place or likely to be in place in time (May). What you can still do is consult the MDR's definition of Medical Device:
‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
— diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
— investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
— providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations,
and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
The following products shall also be deemed to be medical devices:
— devices for the control or support of conception;
— products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point.
 
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